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Following on from our previous article on what it means to have accurate, up-to-date translations that are faithful to the master version , this article describes how to manage local adaptations without compromising compliance. At first glance, adapting instructions for use (IFUs) to a local market may appear to be nothing more than a simple language localisation task. However, under the MDR and...
For medical device manufacturers, PRRCs and QARA teams, the requirements of Regulation (EU) 2017/745 (MDR) for IFUs, labelling and accompanying documentation go beyond simply “having the correct translation”. The Regulation stipulates that the information supplied by the manufacturer must be understandable, consistent and kept up-to-date in the languages required by each Member State. The purpose...
The global translation industry is in the middle of its biggest disruption since the arrival of last generation of CAT tools. Language service providers, publishers and in-house teams are all asking the same question: what does artificial intelligence really change – and how fast? Market studies show that the wider language services industry was worth roughly USD 72 billion in 2024, after mid-...
Amid international growth and European regulatory requirements (such as Regulation (EU) 2017/745 on medical devices), many companies, particularly those operating in the medical sector, must ensure that all their documentation is available in the official languages of the countries where they intend to market their products. If you are considering expanding into the Irish market, translating into...
The International Organization for Standardization (ISO), founded in 1947, is the world's leading body in the creation of standards that ensure the quality, safety, and efficiency of products and services. One of its most recognised standards is ISO 9001, the quality management system applicable to any type of organisation that wishes to continuously improve its processes and consistently meet...
The International Organization for Standardization (ISO), founded in 1947, is the world’s leading body in the creation of standards that ensure the quality, safety, and efficiency of products and services. In the healthcare and medical devices sector, ISO 13485 sets the requirements for a sector-specific quality management system, ensuring that processes comply with the most stringent...
The International Organization for Standardization ( ISO ), founded in 1947, is the most recognised international authority for establishing standards that ensure quality, safety, and efficiency in products and services worldwide. In the field of professional translation, this organisation defines specific standards that allow agencies to offer a reliable, documented service in accordance with...
The world of professional translation is built on a delicate balance between freelance translators and translation agencies . Both play a key role in ensuring that all kinds of content, such as technical texts , are properly adapted to different languages and cultures. However, many are unaware of how the collaboration between freelance translators and agencies actually works. In this article, we...
While translations generated by public AI tools may appear cost-effective, they often cause professionals to lose valuable time. Find out why only a translation agency using professional AI tools can ensure quality, consistency, and genuine cost savings. [TOC] A telling analogy: the DIY haircut Picture this: you book an appointment at the hairdresser, but before going, you decide to cut your own...
Legal translation plays a strategic role in protecting the interests of companies and individuals on the international stage. In a world where trade, partnerships, and contractual obligations extend far beyond borders, it is essential that official documents are clear, valid, and enforceable in the language of the relevant country. [TOC] Why is Legal Translation Crucial Overseas? Legal...









